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Recruiting NCT03154697

Development of Clinical Database of Individuals With Smith-Magenis Syndrome and Sleep Disturbances

— Observational Sleep Disturbances in Smith-Magenis Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Data collection of sleep disturbances in individuals with SMS.
Who it may be relevant to
Registry conditions: Sleep Disturbances in Smith-Magenis Syndrome. Basic parameters: 3 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Development of Clinical Database of Individuals With Smith-Magenis Syndrome

Overview

This database will be used to better understand the sleep problems of people with SMS. This clinical database will be a part of a larger Smith-Magenis Patient Registry used to create an awareness campaign around SMS and the sleep disturbances that are characteristic of the disorder.

Interventions

  • Other Data collection of sleep disturbances in individuals with SMS
    Data related to Smith-Magenis syndrome and sleep disturbances are collected through a web or phone survey

Primary outcome measures

  • Number of individuals with Smith- Magenis syndrome [Time frame: 5 years]
Secondary outcome measures (1)
  • Sleep Disturbances [Time frame: Up to 100 weeks]

Eligibility criteria

Inclusion criteria

  • Parent or legal guardian of individual with Smith-Magenis Syndrome

Exclusion criteria

  • Not legal guardian of individual with SMS

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

United States · 1 center
  • Vanda Pharmaceuticals — Washington D.C.

Identifiers

NCT: NCT03154697 · Pro00015678

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗